BS EN 12523:1999:2003 Edition
$198.66
External limb prostheses and external orthoses. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2003 | 60 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | BRITISH STANDARD |
| 2 | National foreword |
| 4 | Foreword Contents |
| 5 | 1 Scope 2 Normative references |
| 6 | 3 Definitions 3.1 (external limb) prosthetic device; external limb prosthesis 3.2 (external) orthotic device; external orthosis 3.3 user 3.4 attendant 3.5 technical documentation 3.6 clinical evaluation |
| 7 | 3.7 clinical investigation 3.8 knee joint 3.9 side member 3.10 joint assembly 3.11 parallel side member 3.12 stepped side member 3.13 bending deformation 3.14 angular deflection 3.15 limit of proportionality 3.16 stiffness 3.17 maximum bending moment |
| 8 | 3.18 bending deformation at the maximum bending moment 4 General requirements 4.1 Risk analysis 4.2 Intended performance and technical documentation 4.3 Clinical evaluation 4.4 Strength |
| 9 | 5 Requirements for materials 5.1 Flammability of materials and toxicity of combustion products 5.2 Biocompatibility, contaminants and residues 5.3 Infection and microbiological contamination 5.4 Resistance to corrosion 6 Noise and vibration 7 Electromagnetic compatibility (EMC) |
| 10 | 8 Electrical safety 8.1 General 8.2 Battery-powered prosthetic and orthotic devices 8.3 Circuit protection 8.4 Electronic programmable systems 8.5 Electrically-heated blankets, pads and similar flexible heating appliances 8.6 Prosthetic and orthotic devices with skin contact electrodes |
| 11 | 9 Surface temperature 10 Sterility 11 Design requirements 11.1 Safety of moving parts 11.2 Safety of connections 12 Mechanical requirements 12.1 Restrictions on use |
| 12 | 12.2 Forces in soft tissues of the human body 12.3 Ergonomic principles 13 Information supplied by the manufacturer 14 Packaging |
| 13 | Annex A (informative) Guidance on methods of determining the strength of upper limb prosthetic devices A.1 Principle A.2 Test samples |
| 14 | A.3 Number of required tests Table A.1 – Minimum number of tests A.4 Accuracy A.5 Static tests |
| 15 | A.6 Cyclic tests |
| 17 | Figure A.1 – Examples of test sample configurations |
| 18 | Figure A.2 – Test sample segment lengths |
| 19 | Figure A.3 – Configuration of test 1 |
| 20 | Figure A.4 – Configuration of test 2 and test 4 Figure A.5 – Configuration of test 3 and test 5 |
| 21 | Annex B (normative) B.1 Definitions B.2 Principle B.3 Apparatus |
| 22 | B.4 Preparation of test specimens B.5 Procedure |
| 24 | B.6 Calculation of results |
| 25 | Figure B.1 – Example of a bending moment/angular deflection curve: single�stage failure ( |
| 26 | Figure B.2 – Examples of bending moment/angular deflection curves: two�stage failures ( |
| 27 | Figure B.3 – Arrangements of the four-point loading system |
| 29 | Figure B.4 – Example of a test rig design suitable for the application of the four-point loading system |
| 30 | Figure B.5 – Test orientations for joint assemblies intended to restrain motion in four directions mutually at… |
| 31 | B.7 Test report |
| 32 | Table B.1 – Example of test report |
| 33 | Annex C (informative) Guidance on methods of determining the flammability and toxicity of combustion prod… C.1 Principle C.2 Test submission document C.3 Safety requirements C.4 Test Samples |
| 34 | C.5 Test Arrangements |
| 35 | C.6 Test Procedures |
| 37 | C.7 Determination of the “total toxic potential dose” (TTPD) C.8 Pass/fail criteria C.9 Test report |
| 38 | Figure C.1 – Test sample dimensions: trans-femoral (above knee) — finished limb |
| 39 | Figure C.2 – Test sample dimensions: trans-tibial (below-knee) — finished limb |
| 40 | Figure C.3 – Test sample dimensions: trans-femoral (above knee) — socket former |
| 41 | Figure C.4 – Test sample dimensions: trans-tibial (below-knee) — socket former |
| 42 | Figure C.5 – Radiant heat source test |
| 43 | Figure C.6 – Flaming ignition source test |
| 44 | Figure C.7 – Sample support frame and weighing platform |
| 45 | Table C.1 – Worked example of calculating the “total toxic potential dose” (TTPD) |
| 46 | Annex D (informative) Guidance on methods of establishing the force required to operate the controls on p… D.1 Principle D.2 Test samples |
| 47 | D.3 Number of required tests D.4 Accuracy |
| 48 | D.5 Methods of testing |
| 50 | D.6 Test results |
| 51 | Figure D.1a) |
| 52 | Figure D.1b) |
| 53 | Figure D.2 – Specimen orthotic elbow test joint test set up Table D.1 – Ranges of operating force |
| 54 | Figure D.3a) |
| 55 | Figure D.3b) |
| 56 | Figure D.4 – Specimen prosthetic elobow unit test set up |
| 57 | Figure D.5 – Specimen prosthetic terminal device test set up |
| 58 | Annex E (informative) Bibliography Annex Z (informative) Clauses of this European Standard addressing essential requirements or other provis… |
| 59 | Table Z.1 – Correspondence between this European standard and EU Directives |
